HYDRALAZINE HYDROCHLORIDE
- Product NDC
- 55289-133
- 11-digit product format
- 552890133
- Labeler code
- 55289
- Product ID
- 55289-133_47e36800-0665-cf64-e063-6294a90a85af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydralazine hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA086242
- Marketing category
- ANDA
- Marketing start
- 2007-04-06
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- HYDRALAZINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDRALAZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 905225 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55289-133-60 | HYDRALAZINE HYDROCHLORIDE | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 17 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55289-133 | HYDRALAZINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] | 15 | Current NDC, Legacy NDC, 1 package rows | 20240312_4671cefa-4468-4116-ba40-3d3b0f581ea1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55289-133-60 | 55289013360 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-133-60) | 2022-06-24 | 0000-00-00 | No | No | Current |